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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL ACETABULAR REAMER SHELL 47MM

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GREATBATCH MEDICAL ACETABULAR REAMER SHELL 47MM Back to Search Results
Model Number 00-1206-090-47
Device Problem Monitor failure
Event Date 02/18/2015
Event Type  Malfunction  
Event Description

It was reported the surgeon repeatedly complains the reamers are too dull to cut through bone and has to exert tremendous pressure to get the proper fit for implants. Another set of reamers was used to complete the procedure. It is unknown if there were adverse events as a result of the malfunction.

 
Manufacturer Narrative

The device was returned to greatbatch medical and evaluation is in process. Once greatbatch medical completes the investigation, a supplemental medwatch 3500a form will be submitted. Complaint information was provided by zimmer.

 
Manufacturer Narrative

Complaint sample was returned for evaluation and the reported event was not confirmed. A manufacturing review was completed and no discrepancies were found. No further investigation required.

 
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Brand NameACETABULAR REAMER SHELL 47MM
Type of DeviceREAMER SHELL
Manufacturer (Section D)
GREATBATCH MEDICAL
tijuana, baja california
MX 
Manufacturer (Section G)
GREATBATCH MEDICAL MEXICO (GMM)
Manufacturer Contact
noe rivera
4545 kroemer rd.
fort wayne , IN 46818
2607557490
MDR Report Key4737169
Report Number3007882731-2015-00002
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type Distributor,DISTRIBUTOR
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup
Report Date 03/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number00-1206-090-47
Device Catalogue NumberT2768
Device LOT Number56559046
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/03/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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